Axon seminar Functional & Medical Foods

IE-Forum AXON Lawyers On 24 September 2014 our firm organizes a seminar addressing the developments in Functional and Medical Foods. Where? Next door to our office in Pakhuis de Zwijger.

Functional foods

The Institute of Medicine has designated functional food as “any food or food ingredient that provides a health benefit beyond its nutritional benefit”. Functional foods comprise food supplements, probiotics and other foods having a beneficial effect on human health, which is often advertised by health or nutrition claims as using those claims in connection with this type of foods is very attractive from a marketing point of view.

Medical foods

Functional foods are just one step away from medical foods, catering for particular nutritional needs that regular foods do not supply. Contrary to functional foods, medical foods are highly regulated. Furthermore, both types of food are subject to specific legislation regarding health and nutrition claims as well as regarding food information to be provided to consumers.

The regulatory requirements for health and nutrition claims offer a chance and a challenge. Also, as of 13 December 2014, all food business operators have to comply with very strict, new information requirements on the basis of the Regulation on Food Information to Consumers. To what extent does this regulation help the final consumer to make healthy choices and how does this impact the entrepeneur? Our seminar will address these issues and provides practical guidance on solutions. Speakers are: Bernd Mussler (Innovation Project Manager at DSM), Ruud Albers (CEO at Nutrileads) and us (Karin Verzijden and Sofie van der Meulen).

Ore_363832 The benefits of wine.

A few spots left!

We still have a few spots left! Attendance is free and you are welcome to bring along your colleagues. More info? Check the invitation on our website. For registration, please send an e-mail to info@axonlawyers.com with your name, the names of colleagues you would like to register and contact information. Questions? Contact our office manager Marjon Kuijs at marjon.kuijs@axonlawyers.com or +31 (0) 88 650 6500.

Looking forward to see you there!

 

Missed our seminar? Download our slides!

The slides of our seminar on medical and functional foods can be found here and also via our SlideShare account.

 


Glimpse of IFT 2014

IFT2014From 21 – 24 June, the yearly conference of the International Food Technologists (IFT) took place in New Orleans, Louisiana. During this conference, over 16.000 food science and technology professionals discussed the most recent product, ingredient and technology developments, as well as the potential business impact and regulatory framework. Below, you will find a selection of topics discussed. It will also be commented how these impact food business operators  in the EU.

Functional foods

So far, no proper legal definition exists of functional foods. Since 1984 however, the Institute of Medicine has designated as functional food “any food or food ingredient that provides a health benefit beyond its nutritional benefit”, which I consider a clear working title. In the functional food market, functional beverages are the fastest-growing sector. In the IFT-session “The evoluation of functional beverages” advances in ingredients were discussed, such as new vitamin forms, dietary fibers and certain omega-3 fatty acids. Also, trends towards more natural forms of coloration were discussed, for instance from lycopene and beta-carotene, which also increase antioxidant properties. Obviously, using health claims in connection with these functional foods is very attractive from a marketing point of view. However, this remains a strictly regulated area in the USA, where different rules apply to “classical” health claims, structure function claims and qualified health claims. As discussed in our posts of 8 May 2014 and 2 November 2013,  this is not any different in the EU.

Health benefits of prebiotics

In IFT-session Presenters Detail Gut Health Research some of the latest research was shared on the ways in which prebiotics affect the gut microbiota. Prebiotics are substances that are selectively fermented by gut microbes, thereby delivering health benefits to the host. It was reported that during the last 20 years, research has shown that prebiotic ingredients stimulate the growth of beneficial gut bacteria. Furthermore, evidence has been obtained suggesting that diet can contribute health benefits by changing the composition of the gut microbiota. It was pointed out during this presentation, however, that regulatory bodies like the EFSA have refused to permit health claims for prebiotics. Although this may be true in general, it is not entirely correct for lactulose, regarding which EFSA’s NDA panel acknowledged the beneficial effect consisting of a reduction of transit time.

Allergens

From the session Allergens-Free Food Formulation, it became obvious that allergies (being defined as an abnormal response to a food triggered by the body’s immune system) constitute a prominent item on the agenda of food business operators for the years to come. Currently, millions of people have food allergies and that total is growing. Presenters during this session referred to the statistics from the Centers for Disease Control, according to which food allergies among children surged by 50% between 1997 and 2011. In order to respond appropriately, food manufacturers not only have to formule allergen-free foods, but also create an allergen-free manufacturing environment. Also, all of this should be effectively reflected in the product information, in order to meet the applicable labeling requirements. As reported already in our post of 17 September 2013, with the entry into force of the Food Information Regulation by the end of this year, specific measures apply regarding 14 named allergens, both for pre-packed and non pre-packed food.

Product qualification: food or pharmaceutical?

In the session Food Clinical Trials and IND-applications, it was explained when clinical studies for foods would require the filing of an Investigational New Drug (IND) application. This question was answered based on a recent guidance document (Guidance for Clinical Investigators) issued by 3 organisations involved in the evaluation of drugs, biologicals and food and of course on the basis of the criteria contained in the Federal Food, Drug & Cosmetic Act (FFD&C Act). It was explained that if the intent of the clinical study is to investigate a physiological effect of the food on the structure or function of the body beyond the provision of taste, aroma, or nutritive value, then the study will require the filing of an IND application. Furthermore, guidance can be found in FFD&C Act, according to which a food qualifies as a drug if it is intended for use in diagnosis, cure, mitigation, treatment or prevention of disease and if it is intended to affect the structure or any function of the body inter alia. In the EU, we regularly see legal decisions dealing with similar qualification issues based the European Drug Directive. Clearly, this is a topic in the centre of interest on both sides of the Atlantic. It is therefore expected that US guidance on this topic may be of interest for its European counterparts as well.

Further topics @ IFT and subsequent updates @ FHL

Other topics discussed at IFT were overweight and obesity,  perception of food in media and  GMO’s in the food industry. At FoodHealthLegal, we continue to follow all these topics, and in particular their legal and regulatory implications, with interest and we will provide you with further updates shortly. Please feel free also to join Axon’s life sciences seminar on medical and functional food, which will be held on 24 September 2014.

 


Health claim on water drowns – Decision of the General Court in case T-17/12

gch41884Recently, the General Court has decided a dispute concerning a health claim on water, explaining the concept of a disease risk reduction claim as defined by art. 14 (1) of the Health Claim Regulation. More specifically, the Court has clarified that indicating a ‘risk factor’ is mandatory in order to acquire authorisation for such claim. According to the grapevine, this was a test case for the working of the EU food and advertising rules, which has been much criticised. Anticipating the EU elections, EU criticism is not rare to find. Below you will read however, how this case has contributed to clarification of the notion of a disease risk reduction claim.

Cause of the case

The case was initiated by two German individuals, Moritz Hagenmeyer and Andreas Hahn (“the Claimants”), both food law academics, who submitted an application for authorisation of a health claim via the German Federal Office for Consumer Protection and Food Safety. The claim at stake was ‘Regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance‘. Although the claim seems uncontroversial, EFSA delivered a negative opinion. According to EFSA, the application did not provide a ‘risk factor’ for a human disease that would significantly be reduced by the consumption of water. The Commission followed EFSA’s advice and issued Regulation 1170/2011 refusing the claim applied for. In line with EFSA, the Commission held that the proposed risk factors are measures of water depletion and thus are measures of the disease. Accordingly, as a risk factor in the development of a disease is not shown to be reduced, the claim does not comply with the requirements of the Health Claim Regulation and cannot be authorized.

In Court

Continuing their experiment, the Claimants requested the Court to annul the part of Regulation 1170/2011 that refused the authorisation of their claim. To support their action, nine pleas of law were provided. In response, the European Commission pleaded for inadmissibility of the claim, and alternatively for its lacking justification. The Court however, decided to address the matter on admissibility in final judgment, forcing the Commission to take position on the reasons of justification of the claim. In its defence the Commission enjoyed the support of the Council of the European Union, as the application for intervention was admitted. The majority of the pleas brought before the Court regarded the procedural aspects of the claim authorisation procedure. The material dispute, however, focussed on the risk factor and whether this factor was dispensable.

Broad interpretation of “disease risk reduction claim”?

With their first plea, the Claimants argued that according to the Health Claim Regulation, it is not mandatory to provide for a risk factor in the application for a disease risk reduction claim. In support, they relied, inter alia, on previous case law from the European Court of Justice on health claims. In the first place, they argued that it follows from Green Swan, C-299/12 that in order to qualify as a disease risk reduction claim, such claim does not have to state that the consumption of a particular food significantly reduces the development of a certain disease. In the second place, they deduced from Deutsches Weintor, C-544/10 that the link between the consumption of a particular food and the effect on health, should be interpreted broadly. Even if the Court seems to acknowledge this concept, the Court disagreed, explaining that the concept of a disease risk reduction claim is defined by art. 2 (2)(6) of the Health Claim Regulation, and should be interpreted in this context. Therefore, there can be no distinction between the risk factor of art. 2(2)(6) and the term ‘disease risk’ in art. 14 (1). An indication of one, or multiple risk factors in the development of a human disease is, therefore mandatory for the authorisation of a disease risk reduction claim.

‘Risk Factor’

In rejection of the subsequent pleas, the Court emphasized the importance of the risk factor as component of the disease risk reduction claim. Without an indication for a disease or a risk factor for a disease, the Commission cannot judge the beneficial physiological effect that is required by the Regulation for the claim to be permitted. The Court further explained that it is sufficient when the application implies a risk factor instead of a providing a specific indication (see consideration 92 of the decision) thereof. However water loss in tissues” or “reduced water content in tissues indicated by the Claimant when requested for clarification could not be interpreted as the required risk factors. The Court, following the reasoning of the Commission and the EFSA advice decided that these alleged risk factors should be considered as a measures of dehydration rather than risk factors for developing such disease.

Conclusion

Although the claim chosen for this experiment may give rise to hilarity and the length of proceedings to process it may criticised, this case further tightens up the body of case law around disease risk reduction claims. That is a welcome development. As a general rule, health claims should contribute to properly inform the consumer about the characteristics of food and they should not be misleading. Now imagine the situation that this claim had been authorised and was subsequently used by many food business operators for mineral waters. That would be stating the obvious and not really add to any specific consumer information. After all, the Commission did not deny that scientific evidence had shown the link between dehydration and decrease of performance (see consideration 81 of the decision). It simply clarified the requirements for a disease risk reduction claim and more specifically, the mandatory ‘risk factor’. Those requirements prevented stating the obvious in this case. Cheers!

The author is grateful to Lisanne van Kouterik, intern at Axon Lawyers, for her valuable contribution to this post.

 

 

 

 


Misleading Advertising of Food Supplements – or not?

The role of national customs and self-regulatory bodiesVibovit-bis

Introduction

Recently, the Rotterdam District Court decided a dispute between Omega Pharma and Procter & Gamble on allegedly misleading advertising of food supplements. The product in dispute was Vibovit, a multi vitamins product for mothers and young children marketed by Procter & Gamble (P&G) since January 2014. Although well-known for its consumer products such as detergents and toothbrushes, Procter & Gamble is a new player in the field of food supplements. Omega Pharma is a company focusing on OTC health and care products including food supplements, for instance Davitamon. It holds a market share of 61 % in volume and 65 % in value in this field. Omega Pharma clearly perceives Vibovit as a competing product for Davitamon. No doubt, clear scrutiny of the new competitor in the field of food supplements was the start of this case.

Claims made by Omega Pharma

In a nutshell, Omega Pharma accuses P&G of committing misleading advertising and unfair commercial practises regarding its Vibofit product and also of violation of legislation on health claim, food supplements and labeling. More concretely, Omega Pharma inter alia opposed (1) the claim that Vibofit did not contain any preserving agents, whereas it appeared from the list of ingredients that the product contained potassium sorbate. (2) Furthermore, Omega Pharma complained that the packaging of Vibofit stated it contained only natural colouring agents, as it did not agree that the colouring agents titanium dioxide and carbon dioxide qualified as such. (3) Also, Omega Pharma considered the claim “+Omega 3” mentioned on the Vibofit packaging was made in violation of the Claims Regulation.

P&G’s preliminary defence

As a first preliminary defence, P&G had argued that Octapharma’s claim could not be received by the Civil Court, as Octapharma should have brought this claim before the Dutch self-regulatory body that advises on advertisements for health products (KOAG-KAG). This defence was rejected, as this self-regulatory body is only competent to hear disputes on health claims and not regarding any other claims in the field of food or advertising law. As a second preliminary defence, P&G had advanced that Omega Pharma’s claim actually related to unfair B2C commercial practices and that Omega Pharma could not invoke these rules (meaning their national implementation) against its competitor. This defence was also dismissed, as the Court considered that Omega Pharma was entiteld to invoke the rules on unfair commercial practises, being a lex specialis on the general law of the torts, against P&G.

(1) Evaluation of claim re. preserving agent potassium sorbate

Although the parties agree that potassium sorbate can be used as preserving agent, P&G argues this is not the case at hand. Instead, it uses this compound as a processing agent for the preparation of the yellow colour of the Vibofit gummies. As a result of the carry-over principle, a mimimum quantity of potassium sorbate is present in the final product. However, since this quantity is only 0,00005 %, which is 2.000 times too weak to be able to function as s preserving agent, the Court accepts this defence. As a consequence, the claim “free of preserving agents” is not considered misleading.

(2) Evaluation of claim re. colouring agents titanium dioxide and carbon dioxide

Omega pharma opposes the claims “100 % natural colouring agents” and “no artificial colouring agents”, as it considers that both titanium dioxide and carbon dioxide qualify as synthetic instead of natural colouring agents. Since the Food Additives Regulation does not make a distinction between natural and synthetic colouring agents, P&G relies on evidence from two national authorities to refute Omega Pharma’s claim. The first piece of evidence is a list of additives issued by the Dutch Food Safety Authority (Nederlandse Voedsel en Waren Autoriteit – NVWA) based on their qualification by the Dutch Nutrition Center (Voedingscentrum). This authority qualifies titanium dioxide (E171) and carbon dioxide (E172) as “natural”, as opposed to “synthetic” and “of natural origin, chemically processed”.  The second piece of evidence is an NVWA fact sheet from which is follows that the colouring agents E171 and E172 are not considered synthetic. A consumer survey initiated by Omega Pharma investigating the misleading character of the claims used by P&G was considered not relevant, inter alia because it did not outweigh the opinion of the two Dutch national authorities and it was not considered completely neutral. As a consequence, P&G’s claims were not considered misleading.

(3) Evaluation of health claim +Omega 3

The notion + Omega 3 relates to the nutrition claim “source of Omega-3 fatty acids”. According the Health Claim Regulation, this claim is only allowed where the minimum quantities of 0,3 g ALA or 0,40 mg of the sum of EPA and DHA are met.  One Vibofit gummy contains 2,5 mg Omega 3. As the packaging does not differ amongst ALA, EPA or DHA, it is not clear if the applicable standards are met. P&G however argues that it received prior approval from the self-regulatory body KOAG/KAG regarding its Omega 3-claims. Such approval has such authority that in those cases the Dutch Food Safety Authority usually does not apply any fines. In this particular case however, KOAG/KAG changed its policy after said prior approval was granted. According to the new policy, ingredients claims will only be allowed in as far as no existing health or nutrition claim is in place. Although P&G was not happy with this change, it nevertheless removed the Omega 3 claims from the Vibovit packaging and showed the galley proofs during the hearing. As a consequence, the Court considered that Omega Pharma no longer has sufficient interest re. its claim directed at Omega 3.

Conclusion

From the correspondence exchanged between the parties and reproduced in the judgement, it appears that P&G did not simply dismiss Omega Pharma’s claim but had meticulously prepared this case. Where it estimated that its claims would not hold, it had decided to move and to do so quickly. This is of course a very strategic approach, which quite often is successful to avoid litigation. However Omega Pharma simply decided to go after its new competitor. What is most striking in this case from an EU perspective, is the role of national authorities and national customs formulated by self-regulatory bodies. The prior approval from KOAG/KAG with respect to an ingredients claim for the food supplement Vibovit carried an enormous weight in the present dispute. Also, interpretations of national authorities of European food additives standards proved to be a decisive factor in this case. Therefore, when preparing a case of misleading advertising involving labelling and health and nutrition claims, carefully consider where to initiate it in view of those local customs.

 


Spring College on EU Food Law

Spring!After a succesful Autumn College last year September, this 2 days event on EU Food Law is repeated under the name Spring College. The event will take place on 27 and 28 March in Brussels and offers a unique opportunity to receive a profound insight and practical understanding of the complex legal and regulatory framework on EU Food Law. By means of a interactive and informal approach, this intensive two days training provides crucial knowledge on the legal and regulatory requirements, technical standards and relevant case law regarding two specific food law subjects.

Focusing on Health and Nutrition Claims and Food Information as the subjects which are nowadays at the core of the food industry, the Spring College provides fundamental theoretical and practical knowledge thanks to a number of highly topical presentations and ample opportunity for Q&A. Following the “learning by doing” approach, each day will be concluded by a case study, where the participants will split up in small groups to actively discuss and present their solutions. This will allow for a practical understanding and the application of the issues discussed.

The lecturers are seasoned food professionals stemming from the industry, private practise and consultancy. For the case studies, “tag teams” of two lecturers, providing insights from both the private practise and industry perspective, will be operative. All lecturers will stay for an entire day, so that they will also be available for taking questions outside the slots assigned to them.

Looking forward to see you there!


Just as good as a daily glass of milk

the milkmaidIntroduction

Recently, Advocate General Wathelet rendered his conclusion in a case regarding the claim “Just as good as the daily glass of milk” used for a dairy product consisting of fruit curd. Why is this opinion of interest? It provides clarity on the scope and content of the notion of a health claim. Furthermore, opinions rendered by Advocate Generals have a good predictive power for the likely outcome of the decision by the Court of Justice of the European Union (CJEU). In other words, there is a good chance that said Court will follow the explanation proposed by the Advocate General.

Facts and figures

The German company Ehrmann marketed a fruit curd offered for sale under the name of Monsterbacke in six joint units of each 50 grams. According to the nutrition table of this product, it contains per 100 g 105 kcal of energy, 13 g sugar, 2,9 g fat and 130 mg. calcium. By way of comparison: a glass of milk contains per 100 g also 130 mg calcium, but only 4,7 g sugar. As of 2010, Ehrmann promoted its product with the slogan “Just as good as the daily glass of milk”, whereas none of the information obligations referred to in article 10.2 of the Health Claim Regulation was met. These obligations aim at securing full information on the product bearing a health claim, such as the quantity of the food and the pattern of consumption required to obtain the beneficial effect.

Preceding legal proceedings

The German Centre for Protection against Unfair Competition (Wettbewerbszentrale) took Ehrmann to Court (Landgericht Stuttgart), as it considered the slogan “Just as good as the daily glass of milk” to be misleading. In comparison to milk, Ehrmann’s fruit curd contained much more sugar and this was not mentioned on the packaging. Also, due to its comparison with milk, Ehrmann’s product hinted at containing just as much calcium as milk and thereby alluded to a health benefit. Ehrmann did not agree and argued that its fruit curd was a product comparable to milk in many respects, whereby the difference in sugar was just too small to mention. The first instance Court followed this line of reasoning, but the Appeal Court (Oberlandesgericht Stuttgart) did not. According to this Appeal Court, Ehrmann’s slogan was misleading, because 100 g of Ehrmann’s fruit curd contained much more sugar than 100 g milk. Ehrmann filed a so-called appeal for revision (“Revision”) with the German Supreme Court (Bundesgerichtshof), who dropped the qualification of misleading information, but found instead that the slogan “Just as good as the daily glass of milk” qualified as a health claim.

Case before the CJEU

The one single question that the German Supreme Court referred to the CJEU basically related to the transitional regime applied to the Health Claim Regulation, when the lists of authorized claims were not yet in place. The referring Court wanted to know if at that time (2010) the information obligations referred to above were already applicable. This question was answered in the affirmative, inter alia because the requirements laid down in article 10.2 of the Health Claim Regulation aim to protect the consumer. From that perspective, it would be contradictory to suspend those requirements any time. This would also not be in line with the authorized claims themselves that have an evolutionary character. Even more interesting than the proposed answer to the preliminary question were two other aspects raised by the Advocate General. (1) Is it up the CJEU to confirm whether indeed the slogan “Just as good as the daily glass of milk” qualifies as a health claim and (2) what is in fact the scope and content of the notion of health claim in general?

Qualification of slogan as health claim by CJEU?

The different German instances had taken different views regarding the question whether the slogan “Just as good as the daily glass of milk” qualified as a health claim. Whereas the Stuttgart Appeal Court for instance did not consider this slogan to be a health claim, the German Supreme Court came to a different conclusion. Ehrmann did not agree with this conclusion and considered that the CJEU had to provide guidance to this respect to the German Supreme Court. The Advocate General however does not agree. He is of the opinion that there is no reason to cast doubt upon the qualification of facts by the referring Court. Now that the German Supreme Court did not ask any specific question on the qualification of the slogan at stake as a health claim, it is not up to the CJEU to rule on that issue.

 Scope and content of “health claim” in Deutsche Weintor and Green Swan

The Advocate General did take the liberty to explore the notion of health claim. As a start, he referred to its broad definition as “any claim that states, suggests or implies that a relationship exists between the consumption of a food category, a food or one of its constituents and health”. He then referred to the CJEU decision re. Deutsches Weintor, in which it was held that the notion of “easily digestible” for wines amounted to a health claim. The CJEU reasoned that the definition of health claim provides no information as to whether the relationship between the intake of a food and the claimed beneficial effect must be direct, indirect, or as to its intensity or duration. In those circumstances, the term “relationship” must be understood in a broad sense. This approach of the notion of health claim was confirmed in the CJEU decision Green – Swan Pharmaceuticals. In this decision, the CJEU held that for a claim to qualify as a reduction of disease risk claim, it is not required that such claim expressly states that the consumption of a food significantly reduces a risk factor in the development of a human disease. This is despite the fact that the notion of “significantly” figures in the definition of disease risk reduction claim (art. 1.4.6). To the contrary, it is sufficient that the claim may give the average consumer the impression that the reduction of a risk factor is significant.

 Conclusion

Based on the explanation given of the notion of health claim in the CJEU decisions discussed above, the Advocate General concludes that the slogan “Just as good as the daily glass of milk” also qualifies as a health claim. According to him, the average consumer considers milk as a wholesome product. By linking the fruit curd to milk, an implied health effect is communicated. All the more so, since the relation between the intake of the fruit curd and the alleged beneficial effect is interpreted in a very broad way. As a more general conclusion for this contribution, it should be noted that claims on food products readily qualify as health claims. As a food operator, be aware that you meet all requirements for the use of such claims!

image Johannes Vermeer [Public domain], via Wikimedia Commons


Scientific substantiation of health claims – what’s cooking?

Black cabbageEFSA opinions

Lately, we have seen a number of positive EFSA opinions for various health claims. What do these claims relate to? Who are the applicants for such claims? What type of evidence was relied on? And again: what different types of claims exist and what are the proceedings for requesting such claims? This is to provide you with a recap on the role of evidence in requesting a health claim and what is yet to come.

Types of health claims

Regulation 1924/2006 (the Health Claim Regulation) distinguishes the following types of health claims.

  • General function claims (article 13) of which 222 were approved and published pursuant to Regulation 432/2012;
  • General function claims based on newly developed scientific evidence (article 13.5);
  • Disease risk reduction claims (article 14);
  • Claims regarding children’s health and development (article 14).

This blog post focuses on article 13.5 and article 14-claims that need to go through a case-by-case authorisation procedure.

 Authorisation procedure

Any company wanting to use an article 13.5 or article 14 health claim, should file an application with its national competent authority. For the Netherlands, this is the Netherlands Food and Consumer Product Safety Authority (Nederlandse Voedsel- en Warenautoriteit, NVvA). The national authorities mainly function as a box office and will swiftly forward the application to EFSA. As a very minimum, the application should contain, according to article 15.3 of the Health Claim Regulation:

  • the name of the applicant;
  • the nutrient or other substance for which the health claim is to be made;
  • a proposal for the wording of the proposed health claim as well as its conditions of use;
  • a copy of the studies that have been made with respect to the health claim;
  • if appropriate, a request for protection of proprietary data;
  • a summary of the application.

EFSA subsequently informs the Commission and the other Member States and makes the summary available to the public.

EFSA opinion

Within five months upon receipt of a valid application (“stop the clock” requests for additional information excluded), EFSA shall render an opinion on the requested health claim. Basically, this comes down to evaluate whether there is a cause and effect relationship between the intake of a particular nutrient and the claimed effect. This evaluation is done by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA Panel). Questions addressed in every evaluation of the NDA Panel are the following:

  • Is the food sufficiently characterized? NB When the claim regards a food constituent, it should be measurable by established methods.
  • Who is the target population (e.g. general population, infants, children from birth to the age of three years)?
  • Is the claimed effect a beneficial physiological effect?
  • What is the evidence relied on (e.g. interventional human study, observational human study, in vitro studies, animal studies)?
  • Do the studies contain evidence on the food that is the subject of the claim?
  • Can a cause and effect relationship be established between the food product under evaluation and the alleged health effect?

Recent claims evaluated

Recently, Specialised Nutrition Europe, a trade association representing the interests of the specialized nutrition industry, filed two article 14 applications for claims regarding the contribution of vitamin B5 (panthogenic acid) and vitamin B2 (riboflavin)  to a normal energy yielding metabolism. Furthermore, the French company Aptonia, active in the field of body care for athletes, filed an article 13.5 application for a claim regarding the consumption of glycaemic carbohydrates and recovery of normal muscle function after strenous exercise. Another article 13.5 application was filed by Vivatech, a French consultancy company being part of the Viva Sante Group, for a claim regarding the consumption of hydroxyanthracene derivatives and an improvement of the bowel function. EFSA rendered a positive opinion regarding all these applications. The same did not apply to four article 13.5 applications made by Italsur s.r.l., an Italian company producing frozen vegetable products, for claims regarding the contribution of a combination of vegetables, such as Tuscan black cabbage and tri-coloured Swiss chard, and the protection of blood lipids from oxidative damage, as well as a normal blood cholesterol concentration.

Evidence required unclear

The Health Claim Regulation is not specific on what types of studies are required for scientific substantiation of health claims. As a result, the nature of those studies varies considerably. This is exactly the reason why EFSA organizes, on 20 November 2013, a technical meeting on the reporting of human studies submitted for the scientific substantiation of health claims. EFSA considered that consistent reporting in a harmonized and standard way would benefit both EFSA and its stakeholders.

Evaluation of evidence submitted

Anyhow, the evidence submitted by Italsur in view of the benefits of its frozen vegetable products was considered not substantial enough. Apart from a number of published human studies, who did not refer to the subject of the claim, it consisted of open label single-arm interventions regarding 38 or 49 health volunteers, who were given 300 gr. of the product at stake on a daily basis during 14 days. EFSA considered that on the basis of the data presented, a cause and effect relationship could not be established. Quite to the contrary, the evidence submitted by Specialized Nutrition Europe was evaluated to be satisfactory. This organization had first of all submitted literature studies, which showed a positive effect of vitamin B2 on the mitochondrial function. Furthermore, it relied on consensus opinions dating back to 1998, from which the well established role of riboflavin in energy yielding metabolism was deduced. As a consequence, the claim “Riboflavin contributes to a normal energy yielding metabolism” received a positive advice with respect to the target group, being infants and young children up to the age of 3. Of course it helped that a claim on pantothenic acid and normal energy yielding metabolism in the general population was already assessed with a favorable outcome.

Grant of application for health claim

Once EFSA’s opinion is available, EFSA will forward this to the Commission, the Member States and the applicant and it will also be published. The applicant and the members of public may then make comments to the Commission within 30 days from such publication. In making its decision for granting an application for a health claim, the Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.  Within two months upon receipt of the EFSA opinion, the Commission will send to the Standing Committee a draft decision of permitted health claims. After a decision on the application has been made, the Commission shall without delay inform the applicant and the details will be published in the Official Journal. Health claims authorized in accordance with this procedure may in principle be used by any food operator, unless any restrictions of use apply in view of data protection under article 21 of the Health Claim Regulation.

Conclusion

In order to scientifically support a health claim, substantial evidence is required. This does not necessarily require newly generated evidence. In some cases, EFSA agreed to rely on a combination of literature studies and consensus documents. However, if one initiates studies to substantiate a health claim, the scope thereof should be sufficiently broad. Guidance on what was NOT considered sufficient can be taken from the above. Also, new guidance is to be expected further to the EFSA technical meeting to be held on 20 November 2013. Stay tuned to be updated!

 

 

 

 

 


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